The Analysis of Risk Factors for Recurrent Pregnancy Loss and Prediction of Pregnancy Loss Risk

NCT06249230 | Not Yet Recruiting

• 1 other identifier: IIT-2023-0311
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Based on the comprehensive etiological screening results of patients with recurrent pregnancy loss, including basic characteristics, coagulation function indicators, autoimmune indicators, endocrine indicators, and gynecological ultrasound examination results, as well as the outcome of subsequent pregnancy after the patient's visit, analyze the independent risk factors affecting recurrent pregnancy loss, construct and validate an abortion risk prediction model to predict the risk of subsequent pregnancy loss in patients with recurrent pregnancy loss, and classify the patient's risk, Screening high-risk populations and guiding clinical early intervention and active treatment to improve pregnancy success rates.

Conditions

Recurrent Miscarriage

Keywords

recurrent miscarriage; predictive modelling; risk stratification

Outcome Measures

Primary Outcomes (2)

• Number of participants with pregnancy success

  If patients were followed up with a live intrauterine pregnancy beyond 32 weeks, the pregnancy outcome was determined to be a successful pregnancy and the reproductive immunology clinic follow-up ended .

  Follow-up to 32 weeks of gestation for live intrauterine pregnancies or follow-up cut-off

• Number of participants with pregnancy loss

  Patients with histologically confirmed spontaneous abortion by ultrasound or curettage before 28 weeks of gestation, including biochemical pregnancies and embryonic arrests, were judged as pregnancy loss.

  The time of spontaneous abortion occurring before 28 weeks of gestation after consultation

Study Arms (2)

Pregnancy success

Patients followed up with a live intrauterine pregnancy beyond 32 weeks were judged as pregnancy success.

Diagnostic Test: Hematologic features; Diagnostic Test: Ultrasound indices of uterine artery blood flow; Other: Demographic characteristics

Pregnancy loss

Patients with histologically confirmed spontaneous abortion by ultrasound or curettage before 28 weeks of gestation, including biochemical pregnancies and embryonic arrests, were judged as pregnancy loss

Diagnostic Test: Hematologic features; Diagnostic Test: Ultrasound indices of uterine artery blood flow; Other: Demographic characteristics

Interventions

Hematologic features DIAGNOSTIC_TEST

Hematologic features include coagulation indicators, autoimmune indicators, and endocrine indicators.

Pregnancy loss; Pregnancy success

Ultrasound indices of uterine artery blood flow DIAGNOSTIC_TEST

Ultrasound indices of uterine artery blood flow include endometrial thickness, endometrial artery blood flow parameters , and bilateral uterine artery blood flow parameters.

Pregnancy loss; Pregnancy success

Demographic characteristics OTHER

Demographic characteristics include age, the number of previous spontaneous abortions (including biochemical pregnancies), BMI, fertility history, past disease history, chromosomal status, family and genetic history, etc.

Pregnancy loss; Pregnancy success

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients who had two or more spontaneous miscarriages (including biochemical pregnancies, excluding spontaneous miscarriages due to chromosomal abnormalities in the embryo) before 28 weeks of gestation with the same partner prior to the consultation were included in this study

You may qualify if:

• Diagnosis of recurrent miscarriage: patients who had two or more spontaneous miscarriages (including biochemical pregnancies, excluding spontaneous miscarriages due to chromosomal abnormalities in the embryo) before 28 weeks of gestation with the same partner prior to the consultation were included in this study;
• ≥20 years old;
• Completion of initial history taking and complete results of the etiological screening programme;
• Knowledge of the purpose and significance of the study, consent and sign the informed consent form;

You may not qualify if:

• Pregnant at the first visit;
• Presence of severe contraindications to pregnancy, making it inadvisable to conceive;
• Voluntary withdrawal from the pregnancy or from the study;
• No pregnancy outcome as of the follow-up endpoint (December 31, 2023), indicating no pregnancy;
• Loss to follow-up, unable to obtain pregnancy outcome;
• Subsequent pregnancy outcomes after the clinic visit included ectopic pregnancy, molar pregnancy, fetal malformations, and pregnancy at the scar site of previous cesarean section.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Abortion, Habitual

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Aimin Zhao, MD

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingyang Li

CONTACT

86+15026849150; 1042217951@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 8, 2024
• Study Start: January 31, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)